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Phase 2 Spectra Study to Evaluate the Safety and Efficacy of OPL-0401 in Patients With Diabetic Retinopathy

NCT05393284 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2024-06-17

No results posted yet for this study

Summary

OPL-0401-201 is a multicenter study to investigate the safety and efficacy of OPL-0401 in patients with diabetes mellitus (DM) with diabetic retinopathy.

Conditions

Interventions

DRUG

OPL-0401 Dose 1

Pharmaceutical Form: Capsule; Route of Administration: Oral

DRUG

Placebo

Pharmaceutical Form: Capsule; Route of Administration: Oral

Sponsors & Collaborators

  • Valo Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Victor Shi, M.D. · Valo Health, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-16
Primary Completion
2024-08-31
Completion
2024-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05393284 on ClinicalTrials.gov